Ultra Processed Food Diet for Obesity

(UPFEH Trial)

Overseen By Kathryn J Whyte, PhD, MS, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Anti obesity

Disqualifiers: Pregnancy, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a history of using anti-obesity medications, you may not be eligible to participate.

Is the Ultra Processed Food Diet generally safe for humans?

Research shows that high consumption of ultra-processed foods is linked to increased risks of obesity, cardiovascular disease, and even higher mortality rates. These findings suggest potential safety concerns with a diet high in ultra-processed foods. ^{1 2 3 4 5}

How does the Ultra Processed Food Diet treatment for obesity differ from other treatments?

The Ultra Processed Food Diet treatment for obesity is unique because it involves varying levels of ultra-processed food consumption (20% vs. 80%) to study its effects on weight gain, unlike traditional treatments that typically focus on reducing processed food intake. This approach is novel as it directly examines the impact of ultra-processed foods on obesity, which is generally associated with increased calorie intake and weight gain. ^{1 3 6 7 8}

What is the purpose of this trial?

Ultra processed food is everywhere in modern society and may contain multiple ingredients that affect the way participants' bodies store energy. Some studies have shown that eating a diet high in ultra processed foods leads to weight gain, but these foods have not been studied enough to understand why. Recently, the gut microbiome has become a potential way to measure energy balance in the human body; this is done by measuring how many calories are in the stool. The investigators propose to test a very high ultra-processed food diet where 80% of calories are coming from ultra processed food and a low ultra processed food diet where 20% of the calories are coming from ultra processed food. This study will compare stool sample energy content of the two diets.

Research Team

Kathryn J Whyte, PhD, MS, RDN

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals with a BMI between 30-40 who have maintained their weight recently, can use an app throughout the study, do their own grocery shopping, and are generally healthy. It's not for pregnant individuals or those with a history of bariatric surgery or anti-obesity medication use.

Inclusion Criteria

My BMI is between 30 and 40.

Weight stable

Otherwise healthy

Exclusion Criteria

I have taken medication for weight loss before.

Pregnancy

I have had or am planning to have weight loss surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Testing

Participants undergo baseline testing including blood draw, metabolic test, and body composition test

1 week

1 visit (in-person)

Diet Phase 1

Participants follow a diet with either 80% or 20% ultra processed food for two weeks

2 weeks

1 visit (in-person) for dietitian meeting

Washout Period

Participants return to their usual diet and do not participate in research activities

2 weeks

Diet Phase 2

Participants switch to the alternate diet (80% or 20% ultra processed food) for two weeks

2 weeks

1 visit (in-person) for follow-up testing

Follow-up

Participants are monitored for changes in microbial taxa and fecal energy loss

1 week

Treatment Details

Interventions

• Ultra Processed Food Diet (20%)
• Ultra Processed Food Diet (80%)

Trial Overview The study compares two diets: one where 80% of calories come from ultra processed foods and another where only 20% do. The focus is on how these diets affect the body's energy storage by analyzing calorie content in stool samples.

Participant Groups

Group I: 80% Ultra processed Experimental Treatment 2 Interventions

Participants will be provided with shopping lists and menus for the two arms of the diet intervention.

Group II: 20% Ultra processed Experimental Treatment 2 Interventions

Participants will be provided with shopping lists and menus for the two arms of the diet intervention.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

UNC Gillings School of Global Public Health

Collaborator

Trials

2

Recruited

800+

Findings from Research

This systematic review and meta-analysis of 12 observational studies found that higher consumption of ultra-processed foods (UPF) is significantly associated with an increased risk of obesity (odds ratio of 1.55) and overweight (odds ratio of 1.36) in the general population.

Every 10% increase in UPF consumption in daily calorie intake correlates with a 7% higher risk of overweight, a 6% higher risk of obesity, and a 5% higher risk of abdominal obesity, indicating a clear link between UPF intake and excess weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis. Moradi, S., Entezari, MH., Mohammadi, H., et al.[2022]

High consumption of ultra-processed foods (UPF) is linked to a significant increase in the risk of overweight/obesity (39%), high waist circumference (39%), and metabolic syndrome (79%) based on a systematic review of 23 studies.

In a large cohort of 183,491 participants followed for 3.5 to 19 years, high UPF consumption was associated with a 25% increased risk of all-cause mortality and a 29% increased risk of cardiovascular disease, indicating serious long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. Pagliai, G., Dinu, M., Madarena, MP., et al.[2023]

In a study of 1082 older adults in Spain, higher consumption of ultra-processed foods (UPFs) was linked to a greater risk of developing dyslipidemia, specifically hypertriglyceridemia and low HDL cholesterol, over a follow-up period of 5 to 7 years.

Participants in the highest tertile of UPF consumption had more than double the odds of developing hypertriglyceridemia and low HDL cholesterol compared to those in the lowest tertile, suggesting that UPF intake may contribute to cardiovascular disease risk through these lipid abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Consumption of Ultra-Processed Food is Associated with Incident Dyslipidemia: A Prospective Study of Older Adults. Donat-Vargas, C., Sandoval-Insausti, H., Rey-García, J., et al.[2023]

In a study of 20 weight-stable adults over 4 weeks, participants consumed significantly more calories (508 kcal/day) while on an ultra-processed diet compared to an unprocessed diet, leading to weight gain.

The increased energy intake from ultra-processed foods was primarily due to higher carbohydrate and fat consumption, suggesting that reducing ultra-processed food intake could be a key strategy for preventing and treating obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Hall, KD., Ayuketah, A., Brychta, R., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Processed Food Consumption Is Associated with Abdominal Obesity: A Prospective Cohort Study in Older Adults. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption and excess weight among US adults. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

High Consumption of Ultra-Processed Food is Associated with Incident Dyslipidemia: A Prospective Study of Older Adults. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Ultra-processed foods and the development of obesity in adults. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Processed Food Consumption Associated with Overweight/Obesity among Chinese Adults-Results from China Health and Nutrition Survey 1997-2011. [2021]